Today there is a growing need to provide controlled access and vessel management during such procedures as stenting, atherectomy and angioplasty. Generally during these procedures there is a high opportunity for the release of embolic material. The emboli may travel downstream from the occlusion, lodging deep within the vascular bed and causing ischemia. The resulting ischemia may pose a serious threat to the health or life of a patient if the blockage forms in a critical area, such as the heart, lungs, or brain.
Several previously known apparatus and methods attempt to remove emboli formed during endovascular procedures by aspirating the emboli out of the vessel of interest using a catheter having an occlusion balloon. These previously known occlusion balloons, however, have various drawbacks, including variability in deployment of the balloon to the desired shape, inefficiency in removing emboli, and/or high cost and complicated processes associated with manufacturing the balloon.
In applicant's co-pending U.S. patent application Ser. No. 09/418,727, filed Oct. 15, 1999, which is incorporated herein by reference in its entirety, applicant describes the use of a bell or pear-shaped occlusion balloon disposed on the distal end of an arterial catheter. The occlusion balloon comprises a compliant material having a variable thickness along its length to provide a bell-shape when inflated. The balloon is affixed to distal end of the catheter so that a distal portion of the balloon extends beyond the distal end of the catheter to provide an atraumatic tip or bumper for the catheter.
The balloon of that catheter may be formed using previously known techniques, such as varying the thickness of the balloon wall to achieve the preferred bell-shape in the deployed position. Such processes, however, can lead to variability in the final product due to the manufacturing process. Because variable thickness balloons present greater difficulties during manufacture than balloons having uniform wall thickness, the cost of such balloons may be higher.
In view of the foregoing limitations of previously known devices, it would be desirable to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to enhance manufacturability of the occlusion balloon.
It also would be desirable to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to reduce manufacturing cost and enhance product yield.
It further would be desirable to provide an apparatus for removing emboli from a vessel comprising a catheter having an occlusion balloon of uniform thickness that facilitates retrograde flow and efficiently removes emboli.